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Effect of Visceral Manipulation on PCOS

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low-calorie diet
Visceral manipulation with diet
Sponsored by
Mahitab Mohammed Yosri Ibrahim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic Ovary Syndrome, Menstruation Disturbances, Caloric Restriction, Manipulation Therapy

Eligibility Criteria

20 Years - 34 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women having PCOS.
  • 25 ≤ BMI ≤ 30 Kg/m2.
  • Waist/hip ratio ≤ 0.80.
  • Women experiencing irregular menstrual cycles.

Exclusion Criteria:

  • Having cardiovascular diseases, diabetes mellitus, and/ or hypertension
  • Having malignancy.
  • Presence of reproductive disorders unrelated to PCOS.
  • Presence of adrenal gland abnormalities.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Diet group

    Visceral manipulation with diet group

    Arm Description

    Giving a low caloric diet

    Giving visceral manipulation added to a low-calorie diet

    Outcomes

    Primary Outcome Measures

    Change of menstrual complaints' severity
    The total score of menstruation- specific domain of polycystic ovarian syndrome questionnaire (PCOSQ) questions, calculated using the following equation: Number of patient/ group x number of questions/ domain. That total score was then used to determine the percentage of change from severity towards the optimal function.

    Secondary Outcome Measures

    Change in the levels of reproductive hormones (FSH, LH, LH/FSH ratio)
    Human LH and FSH enzyme linked immunosorbent assay (ELISA) kits were used to assess the level of LH and FSH in the blood sample taken from each patient.
    Change in weight
    A weight- height scale is used to assess body weight in kilograms.
    Change in Body mass index (BMI)
    BMI is measured by the equation weight (Kg)/ height (m^2)

    Full Information

    First Posted
    August 15, 2021
    Last Updated
    August 31, 2021
    Sponsor
    Mahitab Mohammed Yosri Ibrahim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05029492
    Brief Title
    Effect of Visceral Manipulation on PCOS
    Official Title
    Effect of Visceral Manipulation on Polycystic Ovarian Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2015 (Actual)
    Primary Completion Date
    March 2016 (Actual)
    Study Completion Date
    March 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Mahitab Mohammed Yosri Ibrahim

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The study was conducted to determine the effect of visceral manipulation on menstrual irregularities and hormonal profile in women with polycystic ovarian syndrome. Thirty women were randomly and equally assigned into the group (A) (Control group), who received a low caloric diet (1200 Kcal/day) only for 3 months, and the group (B) (Study group), who received visceral manipulation to the pelvic organs and the related structures in addition to the same low-calorie diet as the group (A). Evaluations pre and post-study were done for body weight, BMI, female reproductive hormones, and menstruation-related problems.
    Detailed Description
    The current study was conducted to determine the effect of visceral manipulation on menstrual irregularities and hormonal profile in women with polycystic ovarian syndrome (PCOS). Thirty women having PCOS were chosen from the outpatient clinic of the faculty of physical therapy, Cairo University. Patients were randomly assigned into two groups equal in number. Group (A) (Control group), 15 PCOS women received a low caloric diet (1200 Kcal/day) for 3 months, while group (B) (Study group), 15 PCOS women received visceral manipulation to the pelvic organs and the related structures (8 sessions, once per week in the first month then once every other week for two months) in addition to the same low-calorie diet as the group (A). Evaluations pre and post-study for body weight, body mass index, female reproductive hormones [luteinizinghormone (LH), follicle-stimulating hormone (FSH) and LH/FSH ratio] and menstruation-related problems were done by weight- height scale, blood analysis, and menstruation-specific domain of polycystic ovary syndrome health-related quality of life questionnaire (PCOSQ), respectively.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Polycystic Ovary Syndrome
    Keywords
    Polycystic Ovary Syndrome, Menstruation Disturbances, Caloric Restriction, Manipulation Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Polycystic ovarian women were assigned to either group (A), receiving a low-calorie diet for three months, or group (B), receiving the same diet as group (A) together with visceral manipulation of the pelvic organs and their related structures for the same study period (three months).
    Masking
    Outcomes Assessor
    Masking Description
    an independent researcher assigned the participants to one of the two study groups, by opening sealed envelopes containing serially ordered numbers. An independent assessor analyzed the patients' blood samples for hormonal profile and another assessor blinded to patients' allocation interviewed the patients for the questionnaire and assessed the weight.
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Diet group
    Arm Type
    Active Comparator
    Arm Description
    Giving a low caloric diet
    Arm Title
    Visceral manipulation with diet group
    Arm Type
    Experimental
    Arm Description
    Giving visceral manipulation added to a low-calorie diet
    Intervention Type
    Other
    Intervention Name(s)
    Low-calorie diet
    Other Intervention Name(s)
    Control group, Group (A)
    Intervention Description
    Low-calorie diet of 1200 kcal for 3 months, modified every two weeks.
    Intervention Type
    Other
    Intervention Name(s)
    Visceral manipulation with diet
    Other Intervention Name(s)
    Study group, Group (B)
    Intervention Description
    Visceral manipulation to the pelvic organs and their related structures (8 sessions, once per week in the first month then once every other week for two months) added to the same low-calorie diet as the group (A).
    Primary Outcome Measure Information:
    Title
    Change of menstrual complaints' severity
    Description
    The total score of menstruation- specific domain of polycystic ovarian syndrome questionnaire (PCOSQ) questions, calculated using the following equation: Number of patient/ group x number of questions/ domain. That total score was then used to determine the percentage of change from severity towards the optimal function.
    Time Frame
    At baseline and after three months of the intervention.
    Secondary Outcome Measure Information:
    Title
    Change in the levels of reproductive hormones (FSH, LH, LH/FSH ratio)
    Description
    Human LH and FSH enzyme linked immunosorbent assay (ELISA) kits were used to assess the level of LH and FSH in the blood sample taken from each patient.
    Time Frame
    At baseline in the second day of menstruation and after three months of the intervention.
    Title
    Change in weight
    Description
    A weight- height scale is used to assess body weight in kilograms.
    Time Frame
    At baseline and after three months of the intervention.
    Title
    Change in Body mass index (BMI)
    Description
    BMI is measured by the equation weight (Kg)/ height (m^2)
    Time Frame
    At baseline and after three months of the intervention.

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    34 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women having PCOS. 25 ≤ BMI ≤ 30 Kg/m2. Waist/hip ratio ≤ 0.80. Women experiencing irregular menstrual cycles. Exclusion Criteria: Having cardiovascular diseases, diabetes mellitus, and/ or hypertension Having malignancy. Presence of reproductive disorders unrelated to PCOS. Presence of adrenal gland abnormalities.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mahitab Yosri, Lecturer of women's health
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Effect of Visceral Manipulation on PCOS

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